NL-OMON32078CompletedPhase 4
Ambulation performance in chronic stroke patients using an implanted drop foot stimulator - AMPECS
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- niversiteit Maastricht
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •* age ><= 18 years;
- •* first ever supratentorial stroke with persistent neurological deficit
- •* post-stroke time between 6 and 24 months;
- •* Diagnosis and stroke severity
- •* BARTHEL INDEX * 15
- •* clinically diagnosed central paresis of the leg;
- •* drop foot, i.e. inability to achieve a normal heel strike during walking
- •* balance and gait-related criteria: subject is an outdoor walker:
- •* Berg Balance score 48/56;
- •* Rivermead mobility index 11/15.
- •* strength MRC grade * 3 at entry into the study
- •* no injury to peroneal nerves and sciatic nerve
- •* ( EMG to exclude peripheral nerve lesion,
- •* trial stimulation to evaluate dorsiflexion and eversion of the foot)
Exclusion Criteria
- •* pacemaker
- •* any medical condition that would exclude the use of a surgical procedure or anaesthetic
- •* pregnancy
- •* inability to read or understand Dutch or receptive aphasia?
- •* no informed consent
Investigators
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